Active, not recruitingPhase 2

Psilocybin Therapy for Depression in Bipolar II Disorder

NCT05065294 · BAP · University of California, San Francisco

Closed to entry

Status

Not accepting participants

Phase 2

Phase

Target enrolment

Study sites

1 US states

What it is testing

Summary

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Safety and tolerability of psilocybin therapy for depression in BD II
Measured over Baseline to 3 months following last drug dose
Recruitment rate
Measured over Baseline to 3 months following last drug dose
Retention rate
Measured over Baseline to 3 months following last drug dose
Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II
Measured over Baseline to 3 weeks following last drug dose
Treatment Satisfaction of study procedures
Measured over Baseline to 3 months following last drug dose
Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II
Measured over Baseline to 11 days following each drug dose
Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II
Measured over Baseline to 3 months following each drug dose
Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II
Measured over Baseline to 3 months following last drug dose

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * Age 18 to 70 * Comfortable speaking and writing in English * Diagnosis of Bipolar Disorder II with current depression * Have a care partner/support person available throughout the study * Able to attend all in-person visits at UCSF as well as virtual visits * Having tried at least one previous medication trials for their bipolar disorder, each lasting at 6 weeks or more. Exclusion Criteria: * Current or previous diagnosis of Bipolar I Disorder * History of schizophrenia spectrum or psychotic disorder * Use of psychedelics within the past 6 months, including MDMA * Current diagnosis of cancer * Seizures that continue to the present * Fear of blood or needles * Regular use of medications that may have problematic interactions with psilocybin, including but not limited to antidepressants (Bupropion allowed), serotonin antagonists, some antipsychotics, dopamine agonists/antagonists, stimulants, opioids, and Lithium. * A health condition that makes this study unsafe or unfeasible, determined by study physicians

Where

1 study site

Facility	City	Region	Country
University of California, San Francisco	San Francisco	California	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05065294 on ClinicalTrials.gov →

Last updated in the registry 2024-09-25. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication

Bipolar II Disorder9

Recruiting in

California115

All 3 trials from University of California, San Francisco →